Duns Number:480868538
Device Description: The CARDIOVIT® CS-200 is a 12-lead ECG device used for the recording, analysis and evaluat The CARDIOVIT® CS-200 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings.
Catalog Number
3.920250
Brand Name
CARDIOVIT® CS-200
Version/Model Number
3.920250
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 10, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K970879
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
cfdfba6a-e4d4-4a85-8063-54c5cedc9670
Public Version Date
March 10, 2021
Public Version Number
8
DI Record Publish Date
September 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |